As the experts have predicted that India will see a possible third wave of COVID-19 in which children would be the most affected. Fearing the possible outburst Drug Controller General of India (DCGI) on May 12 gave approval for Bharat Biotech’s COVID-19 vaccine phase II/III clinical trial for 525 subjects in the age group of 2-18 years at various sites, including AIIMS Delhi, AIIMS Patna and Meditrina Institute of Medical Sciences, Nagpur.
Dr Vasant Khalatkar a senior Pediatrician, and a Principal Investigator in the clinical trial being held at Meditrina Institute of Medical Sciences, Nagpur in a press conference informed that the institute will begin the clinical trial for age group of 2-18 years in coming 8-10 days after getting a nod from the ethical committee.
Dr Khalatkar further added that â€œthe group is further divided into three age groups â€˜2 year- 6 yearsâ€™, â€˜6 years to 12 years’, and â€˜12 year to 18 yearsâ€™ in which 175 children in each group will be administered with the vaccination jabâ€.
â€œThe duration of the Phase II/III clinical trial will be 208 day. During this period the key factor which will be noted will be immunity, reaction, and safety of these beneficiariesâ€ Dr Khadatkar added.
Speaking on the selection of the beneficiaries for the clinical trial he informed â€œthat the selection will be done on the basis of health, those who have not contracted with COVID-19 before, those who do not have any other health issues. Approval of both parents will be taken in audio and video form before beginning of the trialâ€.
This is the first time in India that a Covid-19 vaccine will be tested on children. The clinical trials involve two Covid-19 vaccine shots injected on day 0 and day 28.